BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION INSULIN SYRINGES 3/10ML 31 GAUGE, 6MM

    MDR report key: 15188731 · Received August 8, 2022

    Report

    Report Number
    1920898-2022-00530
    Event Type
    Malfunction
    Date Received
    August 8, 2022
    Date of Event
    July 14, 2022
    Report Date
    August 30, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMI
    UDI-DI
    00681131138383
    PMA / PMN Number
    K212499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (7) 3/10CC, 6MM, 31G RELION SYRINGES IN AN OPEN POLY BAG FROM LOT # 2010773. CUSTOMER STATES THAT A CLEAR LIQUID COMES OUT OF NEEDLE. ALL RETURNED SYRINGES WERE EXAMINED AND NO LIQUID OR ANY OTHER FOREIGN MATTER WAS OBSERVED IN OR ON ANY OF THE RETURNED SAMPLES. ALL SAMPLES WERE ALSO TESTED AND NO FOREIGN MATTER CAME OUT OF THE CANNULA OF ANY SAMPLES WHEN THE PLUNGER ROD WAS FULLY DEPRESSED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 2010773 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. EMBECTA WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CONSUMER THAT WHILE USING THE SYRINGE 0.3ML 31G 6MM, THAT A CLEAR LIQUID CAME OUT OF NEEDLE, OUT OF FOUR SYRINGES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER :  IT WAS REPORTED BY THE CONSUMER THAT A CLEAR LIQUID HAD CAME OUT OF FOUR NEEDLES. DATE OF EVENT (B)(6) 2022 = 3 SYRINGE. SAMPLE STATUS AWAITING SAMPLE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CONSUMER THAT WHILE USING THE SYRINGE 0.3ML 31G 6MM, THAT A CLEAR LIQUID CAME OUT OF NEEDLE, OUT OF FOUR SYRINGES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER :  IT WAS REPORTED BY THE CONSUMER THAT A CLEAR LIQUID HAD CAME OUT OF FOUR NEEDLES. DATE OF EVENT UNKNOWN - FROM THIS BOX. DATE OF EVENT 07-14-2022 = 3 SYRINGE. SAMPLE STATUS AWAITING SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252777 RELION INSULIN SYRINGES 3/10ML 31 GAUGE, 6MM PISTON SYRINGE FMI BD MEDICAL - DIABETES CARE 328521 2010773 00681131138383

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown